Box 6.1 Information that should be provided to potential participants to seek consent for taking part
1113: SPECIAL ISSUES IN fIELD TRIALS IN LMICs
participants about the study have been outlined in Section 2.4. It is important to note that obtaining ‘communal consent’ does not dispense with the need to also seek and gain individual informed consent. However, those from whom communal consent is sought should be able to represent properly the participants and to protect their inter- ests. In reality, judgements about whether or not to participate in a research investiga- tion depend greatly on the level of trust that investigators enjoy in a community. If a participant trusts an investigator to protect their interests, then they are more likely to agree to take part in the research. Participants will generally expect community leaders to protect their interests also and thus the importance of communal consent, as well as individual consent.
Before a community is approached regarding the possible participation of members of the community in a trial, it will usually be necessary to seek permission from the relevant local health authority, including those responsible for the medical care of the population. Subsequently, the initial approach to a community is likely to be best made to those recognized as leaders in the community. Generally, field trials are likely to be carried out by, or in direct co-operation with, the Ministry of Health and local health authorities. In such circumstances, it will usually be appropriate for discussions with community leaders to be initiated by such authorities, or at least to include their active participation. The extent of such discussions, and precisely who within a community should be involved, depends on the nature of the intervention that is to be studied. Most communities are heterogeneous, and sometimes there are factions within a com- munity that have their own leaders whose co-operation must be sought. The people may not recognize those who are considered as the ‘official’ leaders, and others must be brought into discussions. Public notices and public meetings may also be useful.
It must be re-emphasized that obtaining communal consent for a study does not relieve investigators of their responsibility to explain the study procedures and the potential risks and benefits to those individuals who are being invited to participate, and those individuals must also be informed and be aware that they are free to refuse to participate or to withdraw from the investigation at any time without penalty of any kind.
It is also important to stress that consent to participate in a research investigation is not a one-off event in which the ethical requirements are satisfied, for example, once a signature is appended to the informed consent document. Consent to participate in a trial requires an ongoing dialogue between investigators and participants from the start of a trial through to its end. Investigators must take pains to keep participants informed of the progress of a trial, unexpected developments, and other findings, possibly from parallel studies that may impact on the trial.
3.2
Potential benefit and the risk of harm
The simple Hippocratic caveat ‘do no harm’ is not a sufficient guide to ethical decisions concerning trials of interventions. The introduction of a new intervention requires the demonstration of benefit. Furthermore, since almost any intervention procedure in- volves some risk of harm, albeit usually small, it is necessary to assess in intervention trials the balance of benefits against risks. In general, ethical review committees are dis- inclined to approve studies in which healthy persons will be exposed to more than very
CHAPTER 6: ETHICAL CONSIDERATIONS 112
small risks in the context of a research investigation. Thus, it may be unacceptable to carry out a trial using a vaccine associated with serious side effects, even if it offers pro- tection against a disease that is more serious than the side effects. For example, if one person dies as a result of vaccination for every ten persons who are saved from dying, it is unlikely that such a product would be used, even though the ‘public health’ balance appears to be in favour of the vaccine. More weight is given to harm that results from a deliberate medical intervention than is given to the harm done by the ‘natural’ disease against which the intervention protects. Furthermore, legal concerns of litigation may sometimes be given greater weight than would seem appropriate from a strictly public health viewpoint.
A proposed research investigation should be viewed within the context of the overall problems facing the community in which it is to be conducted. The community should have a reasonable expectation of benefiting from the research in both the short and long term. The effects of the conduct of a field trial in a community may be immediate and evident or may be quite subtle. Even the mere presence of the research workers in a community may have side effects (for example, increased cash flow, availability of transport to other centres), and the impact of such effects should be considered in planning the research.
The possibility of long-term harm must be considered, even if there are short-term benefits.
3.3
Incentives
In some circumstances, it may be reasonable to provide direct incentives as an encour- agement to participation in a research project. If this is done, it must be recognized that there may be a fine line between compensating individuals for time and income lost as a result of participation in the study and ‘bribing’ subjects to take part. It may be considered reasonable to give a small snack after a blood sample has been taken, or to repay bus or taxi fares to participants who travel to a research centre, or to give simple medications for minor ailments, but monetary payments to encourage individuals to participate in a trial that are greater than the wages they forego or the expenses they in- curred will usually be viewed as a form of undue inducement. It is difficult to lay down any absolute rules as to what is acceptable, and it is necessary to review each situation on its merits in the local context. The level of compensation to be offered will generally be considered carefully by the local ERC, whose concern will be that the level proposed does not constitute undue inducement for individuals to participate in the research. 3.4
Standard of care
There are two aspects of standard of care that have been much debated in the context of trials in LMICs. The first is with respect to the choice of the control intervention against which the effects of some new intervention is to be compared. This is discussed in Section 3.5. The second is the standard of medical and other care offered to all the participants in a trial. When a trial is conducted in a poor community, the resources available for the trial (including additional medical personnel) may enable the stand- ard of medical care to trial participants to be greatly improved over what would be
113
